83 FR 53275 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

Page Range		53275-53276
FR Document		2018-22959

The Food and Drug Administration (FDA, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 204 (Monday, October 22, 2018)

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53275-53276]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4308]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry: Labeling of Red Blood Cell Units With Historical Antigen 
Typing Results

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, or Agency) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 21, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Draft Guidance for Industry: Labeling of Red Blood Cell Units 
with Historical Antigen Typing Results.'' Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Labeling of Red Blood Cell Units With Historical Antigen Typing 
Results, OMB Control Number 0910-NEW

    The draft guidance document provides establishments that collect 
blood and blood components for transfusion with recommendations for 
labeling RBC units with non-ABO/Rh(D) antigen typing results obtained 
from previous donations (historical antigen typing results). The draft 
guidance provides recommendations to transfusion services for managing 
RBC units labeled with historical antigen typing results. The guidance 
also provides licensed blood collection establishments that choose to 
implement labeling of RBC units with historical antigen typing results 
instructions regarding how to report the manufacturing and labeling 
changes under 21 CFR 601.12.
    Description of Respondents: Establishments that collect blood and 
blood components intended for transfusion.
    Burden Estimate: We believe that the information collection 
provisions in the draft guidance do not create a new burden for 
respondents and are part of usual and customary business practices. 
According to the 30th edition of the AABB Standards for Blood Banks and 
Transfusion Services, RBC units may be labeled as RBC antigen negative 
without testing the current donation if two previous separate donations 
were tested by the collection facility and results of RBC typing were 
found to be concordant. The standards indicate that facilities have the 
option to put the non-ABO/Rh(D) historical antigen typing results on a 
tie-tag or directly on the container label.
    The guidance also recommends establishments that collect blood and 
blood components for transfusion should convey to transfusion services 
the practices for repeating historical RBC typing results on current 
donations and for labeling RBC units with historical RBC antigen typing 
results.
    We believe that collection establishments have already developed 
standard operating procedures for including the non-ABO/Rh(D) 
historical antigen typing results on a tie-tag or directly on the 
container label, and for conveying any change in their antigen typing 
or labeling practices to their consignees, including practices for 
repeating historical RBC typing results on current donations and for 
labeling RBC units with historical RBC antigen typing results.
    In the Federal Register of January 3, 2017 (82 FR 130), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received six comments on the guidance; 
however, no comments were related to the collection of information.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR 601.12 have been approved under OMB control number 0910-0338; 
and the collections of information in 21 CFR

[[Page 53276]]

part 606 have been approved under OMB control number 0910-116.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22959 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices 53275

initially submitted on December 20, DEPARTMENT OF HEALTH AND provides recommendations to
2016. HUMAN SERVICES transfusion services for managing RBC
3. The date the application was units labeled with historical antigen
Food and Drug Administration typing results. The guidance also
approved: August 17, 2017. FDA has
[Docket No. FDA–2016–D–4308] provides licensed blood collection
verified the applicant’s claim that BLA
establishments that choose to
761040 was approved on August 17,
Agency Information Collection implement labeling of RBC units with
2017. historical antigen typing results
Activities; Submission for Office of
This determination of the regulatory Management and Budget Review; instructions regarding how to report the
review period establishes the maximum Comment Request; Draft Guidance for manufacturing and labeling changes
potential length of a patent extension. Industry: Labeling of Red Blood Cell under 21 CFR 601.12.
However, the USPTO applies several Units With Historical Antigen Typing Description of Respondents:
statutory limitations in its calculations Results Establishments that collect blood and
of the actual period for patent extension. blood components intended for
In its applications for patent extension, AGENCY: Food and Drug Administration, transfusion.
this applicant seeks 654 days, 703 days, HHS. Burden Estimate: We believe that the
ACTION: Notice. information collection provisions in the
or 1,099 days of patent term extension.
draft guidance do not create a new
III. Petitions SUMMARY: The Food and Drug burden for respondents and are part of
Administration (FDA, or Agency) is usual and customary business practices.
Anyone with knowledge that any of announcing that a proposed collection According to the 30th edition of the
the dates as published are incorrect may of information has been submitted to the AABB Standards for Blood Banks and
submit either electronic or written Office of Management and Budget Transfusion Services, RBC units may be
comments and, under 21 CFR 60.24, ask (OMB) for review and clearance under labeled as RBC antigen negative without
for a redetermination (see DATES). the Paperwork Reduction Act of 1995. testing the current donation if two
Furthermore, as specified in § 60.30 (21 DATES: Fax written comments on the previous separate donations were tested
CFR 60.30), any interested person may collection of information by November by the collection facility and results of
petition FDA for a determination 21, 2018. RBC typing were found to be
regarding whether the applicant for ADDRESSES: To ensure that comments on
concordant. The standards indicate that
extension acted with due diligence the information collection are received, facilities have the option to put the non-
during the regulatory review period. To OMB recommends that written ABO/Rh(D) historical antigen typing
meet its burden, the petition must comments be faxed to the Office of results on a tie-tag or directly on the
comply with all the requirements of Information and Regulatory Affairs, container label.
The guidance also recommends
§ 60.30, including but not limited to: OMB, Attn: FDA Desk Officer, Fax: 202–
establishments that collect blood and
Must be timely (see DATES), must be 395–7285, or emailed to oira_
blood components for transfusion
filed in accordance with § 10.20, must submission@omb.eop.gov. All
should convey to transfusion services
contain sufficient facts to merit an FDA comments should be identified with the
the practices for repeating historical
investigation, and must certify that a OMB control number 0910–NEW and
RBC typing results on current donations
true and complete copy of the petition title ‘‘Draft Guidance for Industry:
and for labeling RBC units with
has been served upon the patent Labeling of Red Blood Cell Units with
historical RBC antigen typing results.
applicant. (See H. Rept. 857, part 1, 98th Historical Antigen Typing Results.’’ We believe that collection
Cong., 2d sess., pp. 41–42, 1984.) Also include the FDA docket number establishments have already developed
Petitions should be in the format found in brackets in the heading of this standard operating procedures for
specified in 21 CFR 10.30. document. including the non-ABO/Rh(D) historical
FOR FURTHER INFORMATION CONTACT: antigen typing results on a tie-tag or
Submit petitions electronically to JonnaLynn Capezzuto, Office of
https://www.regulations.gov at Docket directly on the container label, and for
Operations, Food and Drug conveying any change in their antigen
No. FDA–2013–S–0610. Submit written Administration, Three White Flint typing or labeling practices to their
petitions (two copies are required) to the North, 10A–12M, 11601 Landsdown St., consignees, including practices for
Dockets Management Staff (HFA–305), North Bethesda, MD 20852, 301–796– repeating historical RBC typing results
Food and Drug Administration, 5630 3794, PRAStaff@fda.hhs.gov. on current donations and for labeling
Fishers Lane, Rm. 1061, Rockville, MD SUPPLEMENTARY INFORMATION: In RBC units with historical RBC antigen
20852. compliance with 44 U.S.C. 3507, FDA typing results.
Dated: October 16, 2018. has submitted the following proposed In the Federal Register of January 3,
Leslie Kux, collection of information to OMB for 2017 (82 FR 130), FDA published a 60-
Associate Commissioner for Policy.
review and clearance. day notice requesting public comment
on the proposed collection of
[FR Doc. 2018–22958 Filed 10–19–18; 8:45 am] Labeling of Red Blood Cell Units With
information. FDA received six
BILLING CODE 4164–01–P Historical Antigen Typing Results,
comments on the guidance; however, no
OMB Control Number 0910–NEW
comments were related to the collection
The draft guidance document of information.
daltland on DSKBBV9HB2PROD with NOTICES

provides establishments that collect The draft guidance also refers to
blood and blood components for previously approved collections of
transfusion with recommendations for information found in FDA regulations.
labeling RBC units with non-ABO/Rh(D) The collections of information in 21
antigen typing results obtained from CFR 601.12 have been approved under
previous donations (historical antigen OMB control number 0910–0338; and
typing results). The draft guidance the collections of information in 21 CFR

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53276 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices

part 606 have been approved under when they will need to, and/or be able can they be mitigated with
OMB control number 0910–116. to update systems and business modifications to the recommendations?
Dated: October 16, 2018. processes. The questions outlined above can be
To accomplish this goal, NCVHS used to guide written submissions to the
Leslie Kux,
conducted several information gathering Subcommittee. Written submissions
Associate Commissioner for Policy. activities and stakeholder engagement should be sent electronically to
[FR Doc. 2018–22959 Filed 10–19–18; 8:45 am] meetings and workshops: In June 2017 NCVHSmail@cdc.gov with
BILLING CODE 4164–01–P the Subcommittee on Standards met ‘‘Predictability Roadmap’’ in the subject
with each of the standards development line no later than November 20, 2018.
organizations (SDOs) to learn about The times and topics for this meeting
DEPARTMENT OF HEALTH AND their individual maintenance processes; are subject to change. Please refer to the
HUMAN SERVICES in August 2017 the Subcommittee held posted agenda at www.ncvhs.hhs.gov for
a visioning exercise with the SDOs and any updates.
National Committee on Vital and Health
Designated Standards Maintenance Contact Persons for More Information:
Statistics: Hearing
Organization (DSMO); and in May 2018, Substantive program information may
Pursuant to the Federal Advisory the Subcommittee conducted a CIO be obtained from Rebecca Hines, MHS,
Committee Act, the Department of Forum with 21 health care technology Executive Secretary, NCVHS, National
Health and Human Services (HHS) experts and senior corporate officers Center for Health Statistics, Centers for
announces the following advisory representing a cross-section of Disease Control and Prevention, 3311
committee hearing. organizations that were end-users of the Toledo Road, Hyattsville, Maryland
Name: National Committee on Vital HIPAA and ACA administrative 20782, telephone (301) 458–4715.
and Health Statistics (NCVHS), standards. The goal of this Forum was Information pertaining to meeting
Subcommittee on Standards. to elicit input for improving the content may be obtained from Lorraine
Date and Times: Wednesday, standards development, update and Doo, MSW, MPH, (410) 786–6597; and/
December 12, 2018: 9 a.m.–5 p.m. (EST); adoption process, and address barriers or Geanelle G. Herring, MSW, (410)
Thursday, December 13, 2018: 9 a.m.–1 to use of those standards. Based on this 786–4466; Centers for Medicare &
p.m. (EST). work, the Subcommittee on Standards Medicaid Services, Office of Information
Place: Omni Shoreham Hotel, 2500 developed a draft Predictability Technology, Division of National
Calvert Street NW, Washington, DC Roadmap comprised of 23 Standards, 7500 Security Boulevard,
20008. recommendations organized under three Baltimore, Maryland, 21244. Summaries
Status: Open. There will be a public major focus areas. The draft of meetings and a roster of Committee
comment period during the final 15 recommendations were presented at the members are available on the NCVHS
minutes of both days of the meeting. September 13–14 NCVHS meeting and website: www.ncvhs.hhs.gov where
Purpose: Health Insurance Portability are posted on the website at: https:// further information including an agenda
and Accountability Act (HIPAA) ncvhs.hhs.gov/wp-content/uploads/ and instructions to access the live audio
legislation from 1996, as amended,1 2018/09/Presentation-NCVHS-Draft- broadcast of the meeting will be posted.
directed the Secretary of Health and Predictability-Roadmap-Recs- Should you require reasonable
Human Services (HHS) to publish Coussoule-and-Goss.pdf. accommodation, please contact the CDC
regulations adopting standards, code The purpose of this Subcommittee Office of Equal Employment
sets and identifiers to support the hearing is to obtain input from Opportunity on (770) 488–3210 as soon
exchange of electronic health stakeholders on the draft as possible.
information between covered entities. recommendations designed to improve
The standards are for retail pharmacy Sharon Arnold,
the processes for updating, adopting and
and medical transactions. using standards and operating rules, and Associate Deputy Assistant Secretary for
In its capacity to advise the HHS Planning and Evaluation, Science and Data
developing a formal Predictability Policy, Office of the Assistant Secretary for
Secretary on health data, statistics, Roadmap. The Subcommittee will use Planning and Evaluation.
privacy, national health information the feedback received at this hearing to [FR Doc. 2018–22952 Filed 10–19–18; 8:45 am]
policy, and HIPAA, NCVHS is in the finalize recommendations to the
final stages of the development of a BILLING CODE 4151–05–P
Secretary of HHS.
standards update and adoption Individuals and representatives of
roadmap, referred to as the organizations interested in submitting
Predictability Roadmap. The DEPARTMENT OF HEALTH AND
written testimony are invited to respond HUMAN SERVICES
development of the Predictability to the following questions:
Roadmap has been a year and a half In general, National Institutes of Health
long process, achieved in collaboration 1. Would these recommendations as a
with industry stakeholders and the whole improve the predictability of the National Heart, Lung, and Blood
standards development organizations adoption of administrative standards Institute; Notice of Closed Meetings
(SDOs). The overall vision for the and operating rules?
Predictability Roadmap is that: 2. What additional recommendations Pursuant to section 10(d) of the
• HIPAA covered entities and their are critical to achieve predictability? Federal Advisory Committee Act, as
business associates use the adopted And specifically, amended, notice is hereby given of the
standards and operating rules in a 3. What is the value proposition of following meetings.
daltland on DSKBBV9HB2PROD with NOTICES

consistent way to exchange health each recommendation and what The meetings will be closed to the
information and conduct business; and improvements to the current state do public in accordance with the
• Standards are reliably updated and you believe will arise from each provisions set forth in sections
adopted so that covered entities know recommendation/group of similar 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
recommendations? as amended. The grant applications and
1 Along with Section 1104(c) of the Patient 4. Are there potential unintended the discussions could disclose
Protection and Affordable Care Act (ACA) of 2010. consequences? What are those and how confidential trade secrets or commercial

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Document Created: 2018-10-20 01:49:23
Document Modified: 2018-10-20 01:49:23

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by November 21, 2018.
Contact		JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A- 12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected]
FR Citation		83 FR 53275

83 FR 53275 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration